Recall Z-1581-2025— Philips North America Llc

Name: FDA recall Z-1581-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-25

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2025-02-25. It names 2 FDA 510(k) clearances: K212813, K183040. Product: Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.. Reason: A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2025-02-25
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K212813 — Zenition 70Philips Medical Systems Nederland B.V.·cleared 2021-10-01
K183040 — Zenition 70Philips Medical Systems Nederland B.V.·cleared 2018-12-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.

Reason for recall

A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.

Data sourced from openFDA. This site is unofficial and independent of the FDA.